Non Invasive Vagus Nerve Stimulation in Cerebral Palsy (BOOSTTVNS) - Trial NCT06372028

Timeline & Enrollment

Primary Outcome

Assisting Hand Assessment (AHA),Box and Block Test (BBT),Visuomotor task

Summary

The present study aims to assess, through a randomized controlled trial (RCT), the efficacy
 of transcutaneous Vagus Nerve Stimulation (tVNS) in enhancing the functional changes due to
 an intensive motor training in children and adolescents with Cerebral Palsy (CP).
 Particularly, in two different groups active or sham tVNS will be paired with the Hand-Arm
 Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and we will assess the
 effects on the upper limbs motor ability and daily functioning in 6 to 17 years old patients
 with CP having mild-to moderate upper limb deficits. The investigators hypothesized that,
 thanks to the intensive bimanual training, both the active and the sham group will improve in
 motor functioning. However, taking into account that tVNS has the potential to facilitate in
 a bottom-up way neural plasticity, particularly in chronic disease conditions, the
 investigators hypothesized that active tVNS might improve in a greater and more lasting
 extent than sham tVNS the motor functioning. Moreover, as suggested by previous studies
 investigating the effect of non-invasive brain stimulation (NIBS) in paediatric population,
 the investigators expected that the treatment will be safe and well tolerated. Such a result
 would encourage the use of NIBS to boost the rehabilitative training of motor abilities in
 children and adolescents with CP.

ICD-10 Classifications